KP-10 and Insulin Secretion in Men

Kisspeptin Action on Insulin in Healthy Normal Men Clinical Trial

Official title:

Preliminary Evidence Suggesting That Acute Administration of KP-10 Induces Insulin Secretion in Normal Weight But Not in Obese Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771326
• Other study ID #: Kisspeptin12
• Status: Completed
• Phase: Phase 3
• Start date: October 29, 2013
• Est. completion date: January 10, 2014

Study information

• Verified date: December 2018
• Source: Quaid-e-Azam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Induction of insulin secretion by kisspeptin is observed in mouse, pig, rat, and human islets in vitro and in rats, mice and monkeys in vivo, but its mechanism is not fully clear. The present study was designed to investigate the role of KP-10 on insulin secretion in adult healthy and obese men with insulin resistance. The aim of selection of obese persons for the present study was to investigate the effect of acute KP-10 administration in a metabolically challenged condition where the pancreatic beta cells are already highly activated. The long-term objective of this study was to understand the physiological role of kisspeptin signalling in the regulation of insulin secretion in human health and disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 10, 2014
• Est. primary completion date: November 4, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Normal BMI

• Normal renal function

• Normal liver function

• Normal blood count

Exclusion Criteria:

• Disease history

• Diabetes

• Other trauma

Related Conditions & MeSH terms

• Kisspeptin Action on Insulin in Healthy Normal Men
• Kisspeptin Action on Insulin in Obese Diabetic Men

Intervention

Biological:
• Kisspeptin-10
Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Quaid-e-Azam University

References & Publications (2)

Bowe JE, Foot VL, Amiel SA, Huang GC, Lamb MW, Lakey J, Jones PM, Persaud SJ. GPR54 peptide agonists stimulate insulin secretion from murine, porcine and human islets. Islets. 2012 Jan-Feb;4(1):20-3. doi: 10.4161/isl.18261. Epub 2011 Dec 23. — View Citation

Wahab F, Riaz T, Shahab M. Study on the effect of peripheral kisspeptin administration on basal and glucose-induced insulin secretion under fed and fasting conditions in the adult male rhesus monkey (Macaca mulatta). Horm Metab Res. 2011 Jan;43(1):37-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the response of insulin secretion to acute exogenous kisspeptin administration	The blood samples were obtained and analysed for insulin by Enzyme Linked Immunosorbent Assay to know the differential response of insulin secretion to exogenous kisspeptin-10 administration in healthy and obese men.	Each participant was studied up to 4 hours. Blood samples from each individual was collected for 30 minutes pre and 120 minutes post KP-10 administration, at 30 minutes interval.